NCT05123807 · M.D. Anderson Cancer Center
Secondary Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) for Recurrent Mucinous Ovarian Cancer (HI-MOC Study)
What this study is about
The primary objective is to estimate how long patients live after secondary cytoreductive surgery and HIPEC for women with recurrent primary mucinous ovarian cancer
View original scientific description
The primary objective is to estimate overall survival after secondary cytoreductive surgery and HIPEC for women with recurrent primary mucinous ovarian cancer
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Patients must have histologically or cytologically confirmed recurrent primary mucinous ovarian cancer
- Age ≥18 years
- ECOG performance status ≤ 2
- Prior to surgery, patients must have adequate organ and marrow function as defined below (within 30 days of registration):
- absolute neutrophil count \>1,500/mcL
- platelets \>100,000/mcL
- total bilirubin ≤ 1.5 mg/dL
- creatinine ≤ 1.5 mg/dL
- AST(SGOT)/ALT(SGPT) ≤ 3 X institutional upper limit of normal
- Patients must be \> 2 weeks from prior chemotherapy or radiation therapy, except for bevacizumab treatment which requires \>6 weeks
- Ability to understand and the willingness to sign a written informed consent document (either directly or via a legally authorized representative)
Exclusion criteria
- Patients who are receiving concurrent investigational therapy or who have received investigational therapy within 30 days of HIPEC (investigational therapy is defined as treatment for which there is currently no regulatory authority approved indication)
- Patients with mucinous tumors with pathologic confirmation of a non-gynecologic site of origin
- Patients with known active CNS metastases
- Patients with known hypersensitivity to any of the components of cisplatin
- Patients with a prior or concurrent malignancy who natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
- Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Women who are pregnant or nursing women
- Patients with peripheral neuropathy ≥ grade 2
- History of allogenic transplant
- History of prior HIPEC or intraperitoneal chemotherapy
- Known bulky extra-abdominopelvic disease
- Patients with hearing impairment/tinnitus ≥ grade 2
Where
- Houston, Texas
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 16, 2026 · Source of record for eligibility and locations